Methods for forming anastomoses using magnetic force

ABSTRACT

Methods and devices for forming an anastomosis between hollow bodies using magnetic force to couple anastomotic securing components and create a fluid-tight connection between the lumens of the hollow bodies. End-to-side, side-to-side and end-to-end anastomoses can be created without using suture or any other type of mechanical fasteners, although any such attachment means may be used in conjunction with the magnetic attachment The securing components have magnetic, ferromagnetic or electromagnetic properties and may include one or more materials, for example, magnetic and nonmagnetic materials arranged in a laminated structure. The system of anastomotic securing components may he used in many different applications including the treatment of cardiovascular disease, peripheral vascular disease, forming AV shunts for dialysis patients, etc., and may be sized and configured for forming an anastomosis to a specific hollow body, for example, a coronary artery or the aorta.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to methods and devices for forming an anastomosisbetween two hollow bodies, and more particularly to forming ananastomosis using magnetic force.

2. Description of Related Art

Despite the considerable advances that have been realized in cardiologyand cardiovascular surgery, heart disease remains the leading cause ofdeath throughout much of the world. Coronary artery disease, orarteriosclerosis, is the single leading cause of death in the UnitedStates today. As a result, those in the cardiovascular field continue tosearch for new treatments and improvements to existing treatments.

Coronary artery disease is currently treated by interventionalprocedures such as percutaneous transluminal coronary angioplasty(PTCA), coronary stenting and atherectomy, as well as surgicalprocedures including coronary artery bypass grafting (CABG). The goal ofthese procedures is to reestablish or improve blood flow throughoccluded (or partially occluded) coronary arteries, and is accomplished,for example, by enlarging the blood flow lumen of the artery or forminga bypass that allows blood to circumvent the occlusion. Whatprocedure(s) is used typically depends on the severity and location ofthe blockage. When successful, these procedures restore blood flow tomyocardial tissue that had not been sufficiently perfused due to theocclusion.

Another proposed treatment places the target vessel, e.g., a coronaryartery, in direct fluid communication with a heart chamber containingblood, for example, the left ventricle. Blood flows from the ventricleinto a conduit that is in fluid communication with the artery; as such,this treatment may be described as a ventricular bypass procedure.Benefits of this procedure include obviating the need to manipulate theaorta, for example, as is done when a side-biting clamp is used in atypical CABG procedure to create a proximal anastomosis between thebypass graft and the aorta. Clamping or otherwise manipulating the aortaplaces the patient at risk in some cases due to the likelihood that suchmanipulation will release embolic material into the bloodstream. Somechallenges associated with this procedure include delivering anddeploying the conduit in the patient's body, properly positioning theconduit with respect to the heart chamber and the target vessel, andobtaining beneficial flow characteristics through the conduit and thetarget vessel.

A particularly challenging task that must be performed during CABGprocedures (as well as some ventricular bypass procedures) is suturingthe conduit to one or more vessels. As an example, one end of theconduit may be sutured to a source of blood, such as the aorta, a heartchamber or a blood vessel, while the other end of the conduit is suturedto the target vessel, such as a coronary artery or another blood vessel.The small diameter of the vessels involved (typically from 1 mm to 4 mm)makes creating a handsewn anastomosis a highly technical andtime-consuming procedure. The difficulty in forming the suturedanastomosis is exacerbated when access to the target vessel isrestricted or limited, as in a minimally invasive or percutaneousprocedure. This problem also arises in non-cardiovascular applicationsthat utilize handsewn anastomoses, for example, treating peripheralvascular disease or injury, creating AV (arteriovenous) shunts, etc.

While those in the art have proposed various anastomotic couplingsintended to replace a sutured anastomosis, none has performed wellenough to receive any significant level of acceptance in the field. Manyof the proposed couplings penetrate or damage the target vessel wallacutely or chronically, do not remain patent, fail to produce afluid-tight seal between the conduit and vessel, or are simply toocumbersome and difficult to deliver or deploy.

Accordingly, there is a need in the art for methods and devices forforming a reliable anastomosis between hollow bodies in a relativelyquick, easy and repeatable manner as compared to handsewn anastomoses oranastomoses formed by prior art, suture-free devices.

SUMMARY OF THE INVENTION

According to one embodiment, the invention provides a method usingmagnetism for forming an anastomosis between first and second hollowbodies. Each hollow body has a lumen and an opening extending into thelumen. The method is carried out by positioning a first securingcomponent adjacent the opening in the first hollow body, positioning asecond securing component adjacent the opening in the second hollowbody, and using magnetic force to form an anastomosis between the firstand second hollow bodies with the lumens of the first and second hollowbodies in communication.

According to another embodiment, the invention provides a method usingmagnetism for forming an anastomosis between first and second hollowbodies, each of which has a lumen. The method uses magnetic force toform an anastomosis between first and second hollow bodies so as toplace their lumens in communication. The first hollow body has proximaland distal portions between which the anastomosis is disposed.

According to another embodiment the invention provides a method usingmagnetism for forming an anastomosis between first and second hollowbodies with lumens and openings extending into the lumens. This methodis performed by positioning a first securing component adjacent anopening in the first hollow body, positioning a second securingcomponent adjacent an opening in the second hollow body, and usingmagnetic force to form an anastomosis between the first and secondhollow bodies with the lumens of the first and second hollow structuresin communication. At least one of the securing components is positionedwithout everting the hollow body.

According to still another embodiment, the invention provides a methodusing magnetism for forming an anastomosis between first and secondhollow bodies by positioning a first securing component adjacent thefirst hollow body, positioning a second securing component adjacent thesecond hollow body, and using magnetic force to control the relativeposition of the first and second securing components and to form ananastomosis between the first and second hollow bodies. Theblood-carrying lumens of the first and second hollow bodies are placedin communication, with at least one of the first and second securingcomponents at least partially disposed within the blood-carrying lumenof one of the first and second hollow bodies.

According to another embodiment of the invention, a method for formingan anastomosis between first and second hollow bodies may or may not usemagnetism to facilitate the anastomosis. This method includes steps ofpositioning a first securing component through an opening in the wall ofthe first hollow body and at least partially within the lumen of thefirst hollow body, positioning a second securing component adjacent thesecond hollow body, applying a coupling force to the first and secondsecuring components without penetrating the wall of the first hollowbody, and forming a seal between the first and second hollow bodieswhile placing the lumens of the first and second hollow bodies incommunication. The coupling force is applied at substantially the samelocation at which the seal is formed.

According to yet another embodiment, the invention provides a system forforming an anastomosis between first and second hollow bodies in apatient's body. The system includes first and second securing componentscapable of producing a magnetic field that applies force to maintain thesecuring components in a desired relative position. The first securingcomponent has an opening and is substantially plate-shaped and sized andconfigured to be at least partially received in a lumen of a hollow bodyin a patient's body, and the second component has an opening and issized and configured to be positioned adjacent a second hollow body inthe patient's body for forming an anastomosis between the first andsecond hollow bodies.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

FIGS. 1-5 are perspective views of anastomotic securing componentsconstructed according to various embodiments of the invention;

FIG. 6 is a perspective view showing two hollow bodies adapted to bejoined in communication via an end-to-side anastomosis;

FIG. 7 is a perspective view showing two hollow bodies adapted to bejoined in communication via a side-to-side anastomosis;

FIG. 8 is a perspective view showing two hollow bodies adapted to bejoined in communication via an end-to-end anastomosis;

FIG. 9 is a perspective view of the two hollow bodies shown in FIG. 6along with an anastomotic system including anastomotic securingcomponents constructed according to one embodiment of the invention;

FIG. 9A is a sectional view of the anastomosis shown in FIG. 9;

FIG. 10A is a section view similar to FIG. 9A but including alternativeanastomotic securing components used to join the two hollow bodies;

FIG. 10B is a section view similar to FIG. 10A including otheralternative anastomotic securing components for joining the two hollowbodies;

FIG. 10C is a section view similar to FIG. 10A but showing analternative attachment between a hollow body and an anastomotic securingcomponent;

FIG. 10D is a section view similar to FIG. 10C showing anotheralternative attachment between the hollow body and a securing component;

FIG. 11A is a transverse sectional view taken through an end-to-sideanastomosis formed according to one embodiment of the invention;

FIG. 11B is a transverse sectional view taken through an end-to-sideanastomosis formed according to another embodiment of the invention;

FIG. 12 is a perspective view showing two hollow bodies provided withanastomotic securing components constructed according to one embodimentof the invention, the two bodies adapted to be joined via a side-to-sideanastomosis;

FIG. 13 is a perspective view showing the two hollow bodies of FIG. 12provided with anastomotic securing components constructed according toanother embodiment of the invention;

FIG. 14A is a longitudinal sectional view taken through the side-to-sideanastomosis formed according to the embodiment shown in FIG. 12;

FIG. 14B is a transverse sectional view taken through the side-to-sideanastomosis formed according to the embodiment shown in FIG. 12;

FIG. 15 is a perspective view showing two hollow bodies provided withanastomotic securing components constructed according to one embodimentof the invention, the two bodies adapted to be joined via an end-to-endanastomosis;

FIG. 16 is a perspective view showing the two hollow bodies of FIG. 15provided with anastomotic securing components constructed according toanother embodiment of the invention;

FIG. 17A is a plan view of one of the hollow bodies and securingcomponents shown in FIG. 12;

FIG. 17B is a longitudinal sectional view of the hollow body andsecuring component shown in FIG. 17A;

FIG. 18A is a plan view of the hollow body of FIGS. 17A-17B and asecuring component constructed according to an alternative embodiment ofthe invention;

FIG. 18B is a longitudinal sectional view of the hollow body andsecuring component shown in FIG. 18A;

FIG. 19A is a perspective view of the anastomotic securing componentshown in FIGS. 18A-18B, the component positioned in an opening in ahollow body with a lumen having a stenosis disposed proximal to theopening;

FIGS. 19B-19C show anastomotic securing components constructed accordingto further alternative embodiments of the invention, the componentsbeing shown positioned in the hollow body of FIG. 19A;

FIG. 20A is a perspective view of a delivery device constructed to oneembodiment of the invention, the device being shown in a first position;

FIG. 20B is a perspective view of the delivery device shown in FIG. 20A,the device being shown in a second position;

FIG. 21A is a perspective view of the delivery device shown in FIG. 20Awith a securing component constructed to one embodiment of the inventionmounted thereon, the delivery device being shown in the first position;

FIG. 21B is a perspective view of the delivery device shown in FIG. 21A,wherein the device is shown in the second position as it is beingmanipulated to release the securing component;

FIGS. 22A-22F are sectional views schematically illustrating thedelivery device shown in FIGS. 20A-20B being used to deploy anastomoticsecuring components to form an end-to-side anastomosis according to oneembodiment of the invention;

FIG. 23 is a perspective view of an exemplary application according toone embodiment of the invention;

FIG. 23A is an enlarged view of a portion of the embodiment of FIG. 23but showing a completed anastomosis;

FIG. 24 is a perspective view of another exemplary application accordingto another embodiment of the invention;

FIG. 24A is an enlarged view of a portion of the embodiment of FIG. 24but showing a completed anastomosis;

FIG. 25 is a perspective view of an exemplary application according tostill another embodiment of the invention; and

FIG. 25A is an enlarged view of a portion of the embodiment of FIG. 25but showing a completed AV shunt with two anastomoses.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention relates to methods and devices for forming ananastomosis between first and second (or additional) hollow bodieslocated in a patient's body, for example, a connection between a graftvessel and coronary or peripheral blood vessels, viscera, reproductiveducts, etc. The anastomosis places the hollow bodies, more specificallythe lumens of the hollow bodies, in communication. In the case ofblood-carrying bodies (or other hollow bodies that carry fluid) theanastomosis places the bodies in fluid communication. The hollow bodiesbeing joined may comprise native or autologous vessels, vessels formedof synthetic material such as ePTFE, DACRON®, etc.

FIGS. 1-5 illustrate several exemplary embodiments of anastomoticsecuring components constructed according to the invention for use informing an anastomosis between first and second hollow bodies. FIG. 1shows a securing component 10 with an annular body and an opening 12defined by the body. The component 10 is generally plate-shaped andcircular in plan view with a constant (or substantially constant)thickness and width around its perimeter. The securing component 10 issized and configured to be placed adjacent an opening of a first hollowbody that has been prepared for anastomosis to a second hollow body. Asecond securing component would be placed adjacent an opening of thesecond hollow body for making the anastomotic connection.

FIG. 2 shows an elliptical-shaped, anastomotic securing component 14with an opening 16. The securing component 14 is generally plate-shapedand the opening 16 is configured to provide the securing component 14with larger end portions 18 than side portions 20. FIG. 3 shows aracetrack-shaped securing component 22 with an opening 24. As insecuring component 14, the opening 24 provides securing component 22with larger end portions 26 than side portions 28. FIG. 4 shows asecuring component 30 with an opening 32, two end portions 34, 36 andtwo side portions 38. The securing component 30 has a generallyracetrack-shaped configuration, however, the end portion 36 is largerthan the end portion 34 which provides the component 30 with anasymmetric configuration. Stated otherwise, the opening 32 is notcentrally located with respect to the body of the component 30, unlikethe openings 12, 16 and 24 of respective securing components 10, 14 and22 shown in FIGS. 1-3. Also, the end 36 provides a tapered leading edgefor easier introduction into a hollow body such as a blood vessel.

It will be understood that the specific shape and size of the securingcomponents may be varied from the exemplary configurations depicted inFIGS. 1-4. For example, the thickness or width of the securing componentmay vary along all or part of the body of the component. The anastomoticsecuring components of the invention are preferably, though notnecessarily, plate-shaped, i.e., a first dimension D1 of the componentis less than a second dimension D2 of the component (FIG. 1). Typically,the lesser dimension corresponds to a thickness of the component whilethe larger dimension corresponds to a width or length of the component(or diameter in the case of FIG. 1). Minimizing the thickness of thesecuring component may be desirable for applications in which one ormore components are placed within the lumen of a relatively small hollowbody, e.g., a coronary artery, to reduce the amount of foreign materialin the bloodstream and minimize flow impedance.

It will be noted that the securing components shown in FIGS. 1-4 aregenerally flat; however, they could instead be curved or arcuate, orcomprise a combination of flat and curved sections. Additionally, in theillustrated and preferred construction the shape of each securingcomponent substantially corresponds to the opening therein. That is, thesecuring component and its opening preferably have complementaryconfigurations (e.g., elliptical component, elloptical opening).Nevertheless, the securing component could have anon-complementarily-shaped opening. Finally, while each of theillustrated securing components includes only one opening, more than oneopening could be used if desired.

According to preferred embodiments of the invention the anastomoticsecuring components are formed of or have incorporated therein amaterial capable of producing a magnetic field that acts to maintain thecomponents in a desired positional relationship. The magnetic fieldresults in the securing components maintaining the first and secondhollow bodies in a desired position so as to be in fluid-tightcommunication. The material used to form one or both securing componentsis preferably magnetic, ferromagnetic or electromagnetic.

Each of the securing components shown in FIGS. 1-4 is formedsubstantially entirely of a suitable, magnetic field-producing materialsuch that magnetic force may be generated over the entire area of thecomponent. FIG. 5 shows an alternative embodiment wherein a securingcomponent 40, which has an opening 42 and a racetrack-shapedconfiguration similar to securing component 22 of FIG. 3, has definedportions capable of producing a magnetic field. Specifically, thesecuring component 40 includes magnetic field-producing members 44located at discrete areas which, in the illustrated embodiment, are atthe ends of the component. The remaining areas 46 may be located atalternative (or additional) areas of the securing component 40. Anexemplary reason for providing the securing component 40 with areas 46is to allow the use of a rigid magnetic material for the members 44while still permitting the component to be partially or completelycollapsed, for example, for delivery through a small incision or port,trocar, catheter, cannula, etc., by folding the areas 46.

Suitable materials that may be used to form an anastomotic securingcomponent that is capable of producing a magnetic field include NdFeB(Neodymium Iron Boron), SmCo (Samarium Cobalt), and Alnico (AluminumNickel Cobalt). NdFeB is currently preferred for its forcecharacteristics. The amount of force exerted will depend on variousfactors including the materials used, the size of the magnets and thenumber of magnets. In addition, different applications will call fordifferent force ranges. For instance, it may be desirable to minimizethe force as much as possible while still achieving a fluid-tight andsecure attachment when treating small diameter blood vessels. As anexample, in anastomosing coronary vessels, it is preferred to useanastomotic securing components that produce magnetic force in the areaof less than 0.25 lbs, and more preferably approximately 0.15 lbs orless.

FIGS. 6-8 depict first and second hollow bodies that have been preparedfor anastomosis in three different manners. FIG. 6 shows a first hollowbody 50 with an opening 52 that is adapted to be joined to an opening 54of a second hollow body 56 to form an end-to-side anastomosis. Thecompleted anastomosis places the lumens of the respective hollow bodiesin communication. The opening 52 is formed in the wall of the firsthollow body 50, for example, by incising or punching the tissue of thewall, while the opening 54 is defined by an end of the second hollowbody 56. FIG. 7 shows a first hollow body 58 with an opening 60 adaptedto be joined to an opening 62 of a second hollow body 64, therebyforming a side-to-side anastomosis that places their lumens incommunication. The openings 60, 62 are formed in the walls of the hollowbodies 58, 64, for example, as described above regarding opening 52.FIG. 8 shows a first hollow body 66 with an opening 68 adapted to bejoined to an opening 70 of a second hollow body 72 to form an end-to-endanastomosis. Each opening 68, 70 is defined by an end of its associatedhollow body 66, 72.

FIGS. 9 and 9A show first and second hollow bodies 74, 76 respectivelyprovided with first and second anastomotic securing components 78, 80which are used to create an exemplary end-to-side anastomosis accordingto one embodiment of the invention. As shown best in FIG. 9A, thesecuring component 78 includes two members 78A, 78B disposed on oppositesurfaces of a wall of the first hollow body 74. The securing component80 includes two members 80A, 80B disposed on opposite surfaces of aneverted end of the second hollow body 76. The members forming eachsecuring component 76, 78 may be held in a desired and preferably fixedrelative position by magnetic force, with magnetic force also being usedto hold the two securing components in position. The securing components78, 80 are moved together from the position of FIG. 9A to create afluid-tight anastomosis.

FIGS. 10A-10D depict additional end-to-side anastomoses formed accordingto other embodiments of the invention. FIG. 10A shows a first securingcomponent 82 coupled to a first hollow body 84 and a second securingcomponent 86 coupled to a second hollow body 88. The securing components82, 86 have a laminated structure comprising a layer of material 80capable of producing a magnetic field disposed between two layers ofmaterial 82. The material 82 may also be capable of producing a magneticfield or, alternatively, ferromagnetic or non-ferromagnetic, and maycomprise a metal, polymer, ceramic, etc.

One exemplary application of this particular feature of the inventioncomprises a securing component with a middle layer of NdFeB (NeodymiumIron Boron—magnetic) and two outer layers of 302 stainless steel(non-magnetic). The outer layers are bonded by suitable adhesive to themiddle layer. Alternatively, the two outer layers could comprise amagnetic material, e.g., 440C stainless steel, surrounding a middlelayer that is either magnetic or non-magnetic. As an example, thesecuring component may comprise a 0.008 inch thick magnetic layer andtwo 0.001 inch outer steel layers. It will be understood that thisaspect of the invention may be practiced using other materials.

A benefit of this construction is that it allows the thickness of themagnetic layer to be reduced (which makes the brittle magnet more easilyfractured) because the other layer(s) may be formed of a material whichprovide the assembly with the necessary strength, even if the otherlayer is very thin. In the above example, the steel layers may be verythin yet still able to absorb the load, e.g., the tensile forces thatarise during movement of the hollow body or adjacent tissue. Theparticular overall dimensions of the securing component, as well as thedimensions of individual layer (or layers if a multilayer constructionis used) will of course depend on the application. (As examples, for thesecuring component 22 shown in FIG. 3, the thickness in inches ispreferably less than 0.040, and more preferably less than 0.020, e.g.,approximately 0.015 or even less, e.g., 0.008.)

The ability to form a very thin securing component allows formation ofan anastomosis between relatively small hollow bodies, e.g., coronaryblood vessels. Further, the anastomosis can be formed betweenblood-carrying hollow bodies with one or more of the securing componentslocated in the blood flow path while minimizing the foreign materialexposed to blood.

FIG. 10B shows first and second securing components 90, 92 coupled tofirst and second hollow bodies 94, 96. The first securing component 90comprises a single member 98 positioned within the lumen of the firsthollow body 94 against the interior surface of the wall of the bodyadjacent an opening therein. The member 98 has a coating 100substantially, and preferably completely, surrounding its exteriorsurface. It may be desirable in some applications to apply a suitablecoating, or alternatively, a suitable surface treatment, to all or partof the anastomotic securing component. For example, if the first hollowbody 94 represents a blood vessel such as a coronary or peripheralartery, the securing component 90 will be exposed to the blood flowpath. As such, depending on the material used to the form the member 98,it may be desirable or necessary to coat or otherwise treat its surfaceto promote better thrombogenicity and/or improve flow past theanastomosis site. Some exemplary materials that may be used to coat orotherwise treat an anastomotic securing component constructed accordingto the invention include Gold, Platinum, Titanium Nitride, Parylene,Silicone, Urethane, Epoxy, Teflon and Polypropylene.

FIG. 10C shows an embodiment wherein first and second securingcomponents 102, 104 are coupled to first and second hollow bodies 106,108. Each component 102, 104 comprises a single member formed, asexplained above, of a magnetic, ferromagnetic, or electromagneticmaterial. This embodiment, instead of everting an end of one of thehollow bodies 106, 108, provides the first securing component 102 with aportion 110 configured to attach the end of the first hollow body 106.The portion 110 may take various forms, for example, a DACRON® suturering or bioadhesive. It will be recognized that the portion forattaching the hollow body may be located at different areas of thesecond securing component 104 than shown in FIG. 10C.

FIG. 10D shows an embodiment of the invention similar to that of FIG.10C with first and second securing components 112, 114 coupled to firstand second hollow bodies 116, 118. The means for attaching the firstsecuring component 112 to the first hollow body 116 in this embodimentcomprises an expandable member 120, such as a stent, disposed within thelumen of the first hollow body. The member 120 forces the end of thefirst hollow body 116 against the first securing component 112 to attachthe elements in a fluid-tight fashion. It will be appreciated that theembodiments of FIGS. 10C and 10D are only two of the various ways inwhich a securing component may be coupled to a hollow body withouteverting tissue of the hollow body.

FIG. 11A is a transverse sectional view taken through an end-to-sideanastomosis created by first and second securing components 122, 124which are positioned adjacent openings of first and second hollow bodies126, 128. The securing components 122, 124 are plate-shaped (asdescribed above) and generally flat. FIG. 11B shows first and secondsecuring components 130, 132 constructed according to an alternativeembodiment of the invention positioned adjacent the openings of firstand second hollow bodies 126, 128. The securing components 130, 132 arealso plate-shaped but, rather than being generally flat, are arcuate orcurved. As can be seen, the curvature of the securing components 130,132 maintains the first hollow body 126 in a substantially roundconfiguration as compared to the more flattened-out shape it assumeswhen used with the flat securing components 122, 124.

The arcuate securing components 130, 132 preferably have complementarilyor substantially complementarily radii of curvature to provide an evendistribution of force and good sealing. The securing components of theinvention could, however, have different degrees of curvature, thecurvature of each being either constant or changing over the body of thecomponent. Also, while the illustrated securing components 130, 132extend over approximately 120°, other configurations that extend between0° and 360° could be used if desired, for example, 180°. Finally, whileFIGS. 11A and 11B show, respectively, a pair of flat components and apair of arcuate components, the securing components of each pair used tocreate the anastomosis may have dissimilar configurations to varyingdegrees.

FIGS. 12 and 14A-14B show other embodiments of the invention whereinfirst and second hollow bodies 134, 136 are respectively provided withsecuring components in order to create a side-to-side anastomosis. Theembodiment of FIG. 12 utilizes first and second securing components 138,140 respectively positioned adjacent openings in the hollow bodies 134,136. Each securing component 134, 136 includes a single member that maycomprise one or more materials and one or more layers, as describedabove. The components may be fixed by adhesive or other means or remainin position via magnetic force, as explained above. The securingcomponents 138, 140 are positioned through openings formed in the wallof the hollow bodies 134, 136 and are located within the respectivelumens L1, L2 thereof, as shown in FIGS. 14A and 14B. Once joined, thecomponents 138, 140 form a fluid-tight anastomosis that places the firstand second hollow bodies 134, 136 in communication. If the hollow bodies134, 136 are blood (or other fluid) carrying structures, the anastomosisplaces them in fluid communication and provides a fluid-tight seal.

The embodiment of FIG. 13 uses first and second securing components 142,144 which are respectively positioned adjacent openings in the hollowbodies 134, 136 so as to be partially disposed within the lumensthereof. The opening in each hollow body may be formed by making asurgical incision, removing tissue with a punch, etc. Each securingcomponent 142, 144 includes a pair of members, and each member maycomprise one or more materials and one or more layers. One member ofeach securing component 142, 144 is positioned within the lumen of itshollow body while the other member of the securing component ispositioned on the exterior of the hollow body with tissue capturedbetween the members of each component.

FIGS. 15 and 16 show further embodiments of the invention wherein firstand second hollow bodies 146, 148 are respectively provided with firstand second anastomotic securing components in order to create anend-to-end anastomosis. FIG. 15 shows first and second securingcomponents 150, 152 positioned adjacent respective openings of thehollow bodies 146, 148, each opening being defined by an end of a hollowbody and extending into the lumen thereof.

Each securing component 150, 152 includes a single member that may beconstructed as described above. An end of each hollow body 146, 148 ispassed through the opening defined by a respective securing componentand is then everted over the exterior of the component. As a result,joining the first and second securing components 150, 152 in end-to-endfashion places the everted ends of the hollow bodies 146, 148 in sealedcontact. In a case where the hollow bodies are natural blood vessels,such an anastomosis places the intimal surfaces of the vessels incontact.

The embodiment of FIG. 16 includes first and second securing components154, 156 positioned adjacent the openings of hollow bodies 146, 148,respectively. The securing components 154, 156 each comprise a pair ofmembers constructed as described above. The first securing component 154includes one member 154A positioned around the exterior of the firsthollow body 146 (with the end thereof everted), and another member 154Bpositioned around the opening defined by the end of the hollow body 146,the members 154A, 154B being held in place by magnetic force. The secondsecuring component 156 has the same or a similar construction andincludes members 156A, 156B which are positioned adjacent the end of thesecond hollow body 148. In the embodiments of FIGS. 15-16 the securingcomponents are not located within the lumen of either hollow body andthus are not exposed to fluid or other substances contained therein ormoving therethrough.

Another embodiment of the invention will be described with reference toFIGS. 17A-17B. FIG. 17A shows a hollow body 160 with an opening 162 andan anastomotic securing component 164 positioned adjacent the opening.The securing component 164 is positioned within the lumen L of thehollow body 160 and has an opening 166. The opening 166 is aligned withthe opening 162 in the wall of the body 160 as shown. In some instances,for example, when the securing component is forced through an incisionin the wall, the tissue defining the opening 162 may move over theopening 166 of the securing component 164, as shown in FIG. 17B. Asindicated by reference numeral 168 in FIG. 17B, this reduces theeffective area of the securing component 164 that is available tocommunicate with a second hollow body to which the hollow body 160 isanastomosed (not shown).

FIGS. 18A-18B show the hollow body 160 with the opening 162 of FIGS.17A-17B, however, a securing component 170 constructed according toanother embodiment of the invention is positioned adjacent the opening162. The securing component 170 has an opening 172 and has a feature formaintaining the opening 162 open to flow. The securing component 170comprises a flange 174 and an extension 176 coupled thereto (or formedintegrally therewith). As can be seen, the extension 174 prevents tissuedefining or adjacent the opening 162 of hollow body 160 from migratingor springing back after delivery to reduce the cross-sectional flow areaof the securing component 170.

FIGS. 19A-19C show a hollow body 180 which may, for example, represent apatient's coronary or peripheral artery, the lumen of which is stenosedat S. In FIG. 19A, the hollow body 180 is provided with the anastomoticsecuring component 170 of FIGS. 18A-18B by coupling the securingcomponent to an opening in the wall of the artery, thereby forming asite for creating an end-to-side or side-to-side anastomosis. In FIG.19B, the hollow body 180 is provided with an alternatively configuredanastomotic securing component 182 which includes a flange 184 and adiscontinuous or segmented extension 186 passing all or partly throughthe opening in the wall of the hollow body. FIG. 19C shows a securingcomponent 188 with a multi-part construction including a flange 190 anda separate extension 192 which is received in the opening of the hollowbody 180. It should be understood that these are only a few of thevarious constructions that may be employed in practicing this aspect ofthe invention.

The anastomotic securing components of the invention may be deliveredand deployed in various ways. FIGS. 20A-20B and 21A-21B depict somewhatschematically an exemplary delivery device 200 including a first portion202 operatively coupled to a second portion 204. The first portion 202is fixed to a shaft 206 while the second portion 204 is fixed to shaft208 passing through a slot 210 in the portion 202. The first portion 202defines a support ledge 212 and the second portion 202 similarly definesa support ledge 214. FIG. 20A shows the device 200 in a first positionfor retaining an anastomotic securing component of the invention. Thisposition is shown in FIG. 21A wherein the ledges 212, 214 support asecuring component 216 with the opening 218 of the component surroundinga boss 220 that extends upwardly from the ledges. The boss 220 ispreferably used to help align the securing component on the supportledges 212, 214 and, if used in an application with an opening formed ina side wall of a hollow body, to restrain the surrounding tissue duringplacement.

FIGS. 20B and 21B show the device 200 after it has been moved to asecond position from the position of FIGS. 20A and 21A. This is achievedby moving the shaft 208 in the direction of the arrows to slide thesecond portion 204 with respect to the first portion 202, which movesthe support ledge 214 within the opening 218 of the anastomotic securingcomponent 216 (FIG. 21B). This allows the user to separate the device200 from the securing component 216 once the latter has been positionedat the desired location. As shown, depending on the relative dimensionsand shapes of the respective components it may be necessary to rock orotherwise manipulate the device 200 relative to the securing component216 in order to separate them.

It will be understood that the illustrated delivery device 200 is onlyone possible device suitable for use in placing the anastomotic securingcomponents of the invention, and that it may be modified or replacedwith a different delivery device or system. For example, the deliverydevice 200 could be altered so that both support ledges 212, 214 aremoved with respect to the boss 220 (if used) in order to move fully outof contact with and release the securing component. Any suitablematerial(s) may be used to construct the delivery device 200, it beingappreciated using magnetic or ferromagnetic materials may result inmagnetic interaction with the securing components, which may be desiredto facilitate delivery of the components. The delivery device could alsobe constructed of nonmagnetic or ferromagnetic materials such astitanium, polymers, etc.

For sake of example, the creation of an anastomosis using the deliverydevice 200 and first and second securing components of the inventionwill be described with respect to FIGS. 22A-22F. FIG. 22A shows thedelivery device 200 with a first securing component 222 comprising twomembers 222A, 222B, the former member being supported by the ledges 212,214 of the device 200 while the latter member is held above the ledges(e.g., by magnetic attraction to the device 200). The member 222A isbeing inserted into an opening in the wall of a blood vessel V with astenosis S. The member 222A may be shaped or otherwise treated to easeinsertion into the vessel lumen; for example, the leading edge of themember 222A may be formed as shown in the embodiment of FIG. 5.

FIG. 22B shows the one member 222A of securing component 222 positionedagainst the interior surface of the wall of the vessel and the othermember 222B being moved toward the vessel wall. FIG. 22C shows themembers 222A, 222B in position with the delivery device 200 remaining.FIG. 22D shows the device 200 being removed through first securingcomponent 222, and FIG. 22E shows the securing component 222 remainingin the vessel wall to form what may be characterized as a magnetic portP. The securing component(s) may be provided with a surface treatment,such as coatings, roughened or treated areas, or mechanical projections,to enhance engagement with the wall of the hollow body.

The illustrated securing component 222 defines the magnetic port P andproduces a magnetic field that may be used to couple another vessel tothe port. In FIG. 22F, a graft vessel G provided with a second securingcomponent 224 (which itself includes two members) is anastomosed to theport P with magnetic force holding the first and second securingcomponents 222, 224 in a desired relative position. The invention mayalso be practiced using means for fixing the relative distance betweenthe first and second securing components, for example, to prevent tissuebeing forced or squeezed from the space between the components due tothe application of the magnetic force over time. Such means couldcomprise projections that extend directly between the components and actas a stop, or an intermediate element coupled to the components torestrain them against further movement. It will be recognized thatforming a magnetic port according to the invention may also be used innon-vascular applications, as well as applications not requiring ananastomosis to another vessel, for example, to provide an access to anarea of a patient's body.

Several exemplary applications of the invention will be described withreference to FIGS. 23-23A, 24-24A and 23-25A. FIG. 23 is an anteriorview of a human heart with a graft vessel G having one end 230 attachedto the aorta, e.g., by a sutured anastomosis, and another end 232prepared to be anastomosed to an occluded LAD. One securing component234 is coupled to the end 232 of the graft G by any of the methodsdescribed above, and another securing component 236 is coupled to theLAD adjacent an opening therein. The securing components 234, 236 areformed (at least in part) of materials capable of producing a magneticfield so that they may be attached as shown in FIG. 23A, thereby placingthe graft G in fluid communication with the lumen of the LAD. The graftG could alternatively be attached to the aorta by an anastomotic systemconstructed according to the invention.

FIG. 24 shows another exemplary application of the invention applied tothe heart shown in FIG. 23. A ventriculocoronary shunt S has one end 237placed in the myocardium in fluid communication with the left ventricleLV. The shunt S is provided with a securing component 238 adjacent itsother end while the LAD is provided with the securing component 236 ofFIG. 23. The shunt S is adapted to be coupled to the LAD via aside-to-side anastomosis, therefore the securing component 238 ispositioned in an opening in the side wall of the shunt (and the free endof the shunt is tied off at 240). FIG. 24A shows the completedanastomosis once the securing components 236, 238 have been coupled andremain in position via the magnetic field produced according to theteachings of the invention.

FIGS. 25-25A illustrate yet another example of the many differentapplications of the invention, namely, the creation of an AV shunt. FIG.25 shows a patient's arm including a number of the blood vessels locatedtherein. An artery 242 is shown disposed in relatively close proximityto a vein 244. AV shunts are often created between an artery and vein inorder to provide a site for repeatedly accessing a patient's vascularsystem, for example, to treat dialysis patients. The shunt itself istypically formed of synthetic graft material and can withstand repeatedneedle sticks much better than a natural vein. An AV shunt 246 iscreated between the artery 242 and vein 244 by forming a side-to-sideanastomosis using first and second securing components 248, 250. Theshunt 246 is preferably formed of ePTFE, DACRON® or another suitablesynthetic graft material.

It should be appreciated that the applications of FIGS. 23-23A, 24-24Aand 23-25A represent several of many different uses for the invention.Other applications for the invention include, for example, neurological,urological and gastrointestinal procedures. As a further example, theinvention could be used to form an anastomosis with an existing CABGgraft that has partially or completely occluded over time, for instance,by placing the anastomotic securing components in the graft distal tothe occlusion. In short, it will be recognized that the invention may bemodified in varying degrees from the preferred embodiments illustratedand described specifically herein.

As noted above, it will be recognized that the invention may be used inmany different procedures, for example, femoral-femoral,femoral-popliteal, femoral-tibial, ilio-femoral, axillary-femoral,subclavian-femoral, aortic-bifemoral, aorto-iliac, aorto-profundafemoris and extra-anatomic bypasses. In sum, the invention may be usedto create an anastomosis with many different vessels, including, withoutlimitation, the renal arteries, mesenteric vessel, inferior mesentericartery, eroneal trunk, peroneal and tibial arteries.

The preferred embodiments of the invention are described above in detailfor the purpose of setting forth a complete disclosure and for sake ofexplanation and clarity. It will be readily understood that the scope ofthe invention defined by the appended claims will encompass numerouschanges and modifications.

What is claimed is:
 1. A method for forming an anastomosis between firstand second vessels using magnetic force, the method comprising steps of:selecting a first vessel having a lumen; selecting a second vesselhaving a lumen; securing a first anastomotic component to the firstvessel to define a first contact surface, the first contact surfacebeing formed at least in part by an exposed portion of the firstanastomotic component; securing a second anastomotic component to thesecond vessel to define a second contact surface; and using magneticforce to create an anastomosis between the first and second vessels bycontacting the exposed portion of the first contact surface with thesecond contact surface.
 2. The method of claim 1, wherein the secondcontact surface is formed at least in part by an exposed portion of thesecond anastomotic component.
 3. The method of claim 2, wherein theexposed portions of the first and second anastomotic components contactone another.
 4. The method of claim 1, wherein the first vessel is acoronary artery and the second vessel is a graft selected from the groupconsisting of natural blood vessels and vessels formed of syntheticmaterial.
 5. The method of claim 1, wherein the exposed portion of thefirst anastomotic component contacts the second vessel.
 6. The method ofclaim 1, wherein the magnetic force is sufficient to maintain theanastomosis between the first and second vessels.
 7. The method of claim6, wherein only magnetic force is used to form the anastomosis betweenthe first and second vessels.
 8. The method of claim 1 furthercomprising the step of maintaining the full size of the opening in thesecond vessel.
 9. The method of claim 1, wherein each of the first andsecond anastomotic components includes a material selected from thegroup consisting of magnetic, electromagnetic and ferromagneticmaterials.
 10. The method of claim 1, further comprising the step ofpreventing the first and second anastomotic components from movingtoward each other beyond a predetermined distance.
 11. The method ofclaim 1, wherein at least one of the first and second anastomoticcomponents is secured to a respective vessel without penetrating thetissue of the vessel.
 12. The method of claim 1, wherein at least one ofthe first and second anastomotic components is secured to a respectivevessel without everting the vessel.
 13. The method of claim 12, whereinthe first and second anastomotic components are secured to therespective vessels without everting either vessel.
 14. The method ofclaim 1, wherein the anastomosis is formed without using glue.
 15. Themethod of claim 1, further comprising the step of forming a magneticanastomosis between the second vessel and a third vessel so as to placethe third vessel in communication with the first vessel.
 16. The methodof claim 15, wherein the first and second anastomotic components areunconnected.
 17. A method for forming an anastomosis between first andsecond vessels using magnetic force, the method comprising steps of:selecting a first vessel having a lumen, selecting a second vesselhaving a lumen; securing a first anastomotic component to the firstvessel by capturing tissue of the first vessel between two portions ofthe first anastomotic component that respectively contact an intimalsurface and an exterior surface of the first vessel, wherein the firstanastomotic component is secured to the first vessel by compressing thetissue of the first vessel between the two portions of the component,the two portions of the first anastomotic component compressing theintimal and exterior surfaces of the first vessel as a result ofmagnetic force; securing a second anastomotic component to the secondvessel; and using magnetic force between the first and second componentsto create an anastomosis that places the lumens of the first and secondvessels in communication.
 18. The method of claim 17, wherein the twoportions of the first anastomotic component are separate members. 19.The method of claim 17, wherein the second anastomotic component issecured to the second vessel without contacting an intimal tissuesurface of the second vessel.
 20. The method of claim 17, wherein thesecond anastomotic component is secured to an end of the second vesseland is coupled to the first anastomotic component to form an end-to-sideanastomosis.
 21. The method of claim 17, wherein at least one of thefirst and second vessels includes synthetic material.
 22. The method ofclaim 17, wherein the first vessel is a coronary artery and the secondvessel is a graft selected from the group consisting of natural bloodvessels and vessels formed of synthetic material.
 23. The method ofclaim 17, wherein the magnetic force is sufficient to maintain theanastomosis between the first and second vessels.
 24. The method ofclaim 17, further comprising the step of maintaining the fall size of anopening in the second vessel.
 25. The method of claim 17, wherein eachof the first and second anastomotic components includes a materialselected from the group consisting of magnetic, electromagnetic andferromagnetic materials.
 26. The method of claim 17, further comprisingthe step of preventing the first and second anastomotic components frommoving toward each other beyond a predetermined distance.
 27. The methodof claim 17, wherein at least one of the first and second anastomoticcomponents is secured to a respective vessel without penetrating thetissue of the vessel.
 28. The method of claim 17, wherein at least oneof the first and second anastomotic components is secured to arespective vessel without everting the vessel.
 29. The method of claim28, wherein the first and second anastomotic components are secured tothe vessels without everting either vessel.
 30. The method of claim 17,wherein the anastomosis is formed without using glue.
 31. The method ofclaim 17, further comprising the step of forming a magnetic anastomosisbetween the second vessel and a third vessel so as to place the thirdvessel in communication with the first vessel.
 32. The method of claim17, wherein the first and second anastomotic components are unconnected.33. The method of claim 17, wherein only magnetic force is used tocouple the first and second anastomotic components together.
 34. Themethod of claim 17, wherein the first anastomotic component is securedto an end of the first vessel while the second anastomotic component issecured to a side wall of the second vessel, and the first and secondanastomotic components are coupled to form an end-to-side anastomosis.35. The method of claim 17, wherein the anastomosis is a side-to-sideanastomosis.
 36. A method for forming an anastomosis between first andsecond vessels using magnetic force, the method comprising steps of:selecting a first vessel having a side wall and a lumen; selecting asecond vessel having a side wall and a lumen; securing a firstanastomotic component to the first vessel by magnetic force; securing asecond anastomotic component to the second vessel by a non-magneticattachment; and using magnetic force between the first and secondanastomotic components to create an anastomosis that places the lumensof the first and second vessels in communication; wherein the magneticforce between the first and second anastomotic components is sufficientto maintain the anastomosis between the first and second vessels withoutinterconnecting the first and second anastomotic components.
 37. Themethod of claim 36, wherein only magnetic force is used to create theanastomosis.
 38. The method of claim 36, wherein the first vessel is acoronary artery and the second vessel is a graft selected from the-groupconsisting of natural blood vessels and vessels formed of syntheticmaterial.
 39. The method of claim 36, wherein only magnetic forcebetween the first and second anastomotic components is used to maintainthe anastomosis between the first and second vessels.
 40. The method ofclaim 36, further comprising the step of maintaining the full size of anopening in the side wall of the second vessel.
 41. The method of claim36, wherein each of the first and second anastomotic components includesa material selected from the group consisting of magnetic,electromagnetic and ferromagnetic materials.
 42. The method of claim 36,farther comprising the step of preventing the first and secondanastomotic components from moving toward each other beyond apredetermined distance.
 43. The method of claim 36, wherein at least oneof the first and second anastomotic components is secured to arespective vessel without penetrating the tissue of the vessel.
 44. Themethod of claim 36, wherein at least one of the first and secondanastomotic components is secured to a respective vessel withouteverting the vessel.
 45. The method of claim 44, wherein the first andsecond anastomotic components are secured to the first and secondvessels without everting either vessel.
 46. The method of claim 36,wherein the anastomosis is formed without using glue.
 47. The method ofclaim 36, farther comprising the step of forming a magnetic anastomosisbetween the second vessel and a third vessel so as to place the thirdvessel in communication with the first vessel.
 48. The method of claim36, wherein the first and second anastomotic components are unconnected.49. The method of claim 36, wherein the anastomosis is a side-to-sideanastomosis.
 50. A method for forming an anastomosis between first andsecond vessels using magnetic force, the method comprising steps of:selecting a first vessel having a lumen; selecting a second vesselhaving a lumen; securing a first anastomotic component to the firstvessel by capturing tissue of the first vessel between two portions ofthe first anastomotic component, the two portions of the firstanastomotic component respectively contacting an intimal surface and anexterior surface of the first vessel; securing a second anastomoticcomponent to the second vessel, the second anastomotic component beingsecured to the second vessel without contacting an intimal surface ofthe second vessel; and using magnetic force to create an anastomosisthat places the lumens of the first and second vessels in communication.51. The method of claim 50, wherein the first anastomotic component issecured to a side wall of the first vessel by compressing the tissue ofthe side wall between the two portions of the component.
 52. The methodof claim 50, wherein the two portions compress the intimal and exteriorsurfaces of the first vessel side wall as a result of magnetic force.53. The method of claim 50, wherein the first anastomotic component issecured to an end of the first vessel and is coupled to the secondanastomotic component to form an end-to-side anastomosis.
 54. The methodof claim 50, wherein magnetic force is used to create a side-to-sideanastomosis.
 55. The method of claim 50, wherein the magnetic forcebetween the first and second anastomotic components is sufficient tomaintain the anastomosis between the first and second vessels.
 56. Themethod of claim 50, wherein only magnetic force is used to secure thefirst anastomotic component to the first vessel.
 57. The method of claim50, further comprising the step of maintaining the full size of anopening in the second vessel.
 58. The method of claim 50, wherein eachof the first and second anastomotic components includes a materialselected from the group consisting of magnetic, electromagnetic andferromagnetic materials.
 59. The method of claim 50, further comprisingthe step of preventing the first and second anastomotic components frommoving toward each other beyond a predetermined distance.
 60. The methodof claim 50, wherein at least one of the first and second anastomoticcomponents is secured to a respective vessel without penetrating thetissue of the vessel.
 61. The method of claim 50, wherein at least oneof the first and second anastomotic components is secured to arespective vessel without everting the vessel.
 62. The method of claim50, wherein the first and second anastomotic components are secured tothe vessels without everting either vessel.
 63. The method of claim 50,wherein the first and second anastomotic components are coupled bymagnetic force without being mechanically connected.
 64. The method ofclaim 50, wherein the first vessel is a coronary artery and the secondvessel is a graft selected from the group consisting of natural bloodvessels and vessels formed of synthetic material.
 65. The method ofclaim 50, wherein the anastomosis is a side-to-side anastomosis.